全面品质管制

1、全面品質管制何謂品質質ISO定義:一一個產品品或一項項服務的的整體特特色和性性質，此此特色和和性質讓讓使用者者 覺得得滿意的的程度。臨床檢驗驗服務定定義:在在約定的的費用與與時間內內，以及及約定的的條件下下和事後後必須的的處置，交付可可靠的訊訊息Quality ManagementQP: QualityPlanning(Plan)Purpose :prevent problembyimplementing properprocessesQLP:QualityLaboratorypractices(DO)Purpose :establishlaboratorystandardprocessesQ

2、C:Qualitycontrol (Check)purpose :detectproblem,containthedamageQA:Qualityassurance(Check)Purpose :detectproblem,planimprovementsQI: Qualityimprovement(action)Purpose :prevent problembycorrecting processesStep in thecontrol processChoosewhatistobecontrolled (quality characteristic)Chooseaunit of meas

3、urement (method)Setastandardforthe qualitycharacteristicChooseasensing devicewhichcanmeasurethequalitycharacteristicintermsoftheunitmeasurementMeasure theactualperformanceInterpretthe differencebetweentheactual qualityand thestandardTake action(ifany)onthedifferenceControl MaterialCalibrator:Toestab

4、lishastandardcurve利利用用已知濃濃度的試試劑(standard/calibrator)，測定其其與反應應試劑作作用之能能量變化化；並將將此能量量變化值值與該已已知濃度度值，做做成函數數關係圖圖。Control:Toinvestigatethestandardcurve利利用用已知濃濃度範圍圍的試劑劑(controlserum) ，測測定其與與反應試試劑作用用之能量量變化；並對照照該反應應之standard curve ，將將能量變變化值換換算成濃濃度值後後，比較較是否在原原已知範範圍濃度度內Comparison of qualitycontrolmaterialsCriter

5、iaFrozenLyophilizedLow-temperature liquidCostLowHighHighClarityClearTurbidClearStability12 months1824 months1824 monthsLyophili-zation errorAbsent PresentAbsentSelectionofcontrolmaterialTheanalystsconcentrationshouldbeatmedically significantThematerialshould be availableinlargequantitiesThematerialm

6、atrix shouldbeasmuch likethe human sampleaspossibleConstituentsshould be stableforalong periodoftimeSelectionofcontrolmaterialMaterialshouldhavelowvial-to-vial variabilityAfterthevialhasbeenopenedand thematerialprepareditshouldbestable duringtheperiodofuseThematerialshouldbeready-to-use or requiremi

7、nimumpreparationControl shouldbeimmediatelyavailableinemergency situationsThecontrolmaterialshouldbereasonablypricedExternalProficiencyTesting為Youdon 於1967年提出出的品品管圖，以正常常(低值值)及異異常(高高值)兩兩種品管管同時測測定，製製成雙值值 管理理圖(Twin Plots Method)低值畫在在水平軸軸，高值值畫在垂垂直軸，形成正正方形圖圖，正方方形的中中心點，即為兩兩個平均均值的交交叉點College of American Pa

8、thologistsExternalquality control1946with Belkand Sunderman1947 CollegeofAmericanPathologists(CAP)Performance limitsandgradinga:19661969within+2S as acceptable，exceeding+2Sasnot acceptableb:1970within+1Sasgood，within+2S asacceptable ，beyond +2SasnotacceptableCapsurveysuses acalculatedgrading parametercalledthe standard deviationindex(SDI)SDI=(laboratoryvalue-groupmean)/groupSValuesoutsidethegroupmeans+2SDIlimits areno